BEUDAMED
    FDA Adverse Event Other Summary report: N

    ZENITH AAA LEG GRAFT

    MDR report key: 501711 · Received December 5, 2003

    Report

    Report Number
    1820334-2003-00255
    Event Type
    Other
    Date Received
    December 5, 2003
    Date of Event
    November 10, 2003
    Report Date
    November 10, 2003
    Manufacturer
    COOK INC.
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    MAIN BODY DEPLOYMENT COMPLETED. CONTRALATERAL LIMB CANNULATED WITHOUT DIFFICULTY. SUPRARENAL STENT DEPLOYED, IPSILATERAL LIMB RELEASED. CONTRALATERAL ILIAC LEG INSERTED AND DEPLOYED WITHOUT DIFFICULTY, AND NO RADIOGRAPHIC CONFIRMATION OF THE LEFT HYPOGASTRIC ARTERY. PLANNED ISPILATERAL ILIAC LEG EXTENSION INSERTED WITH A ONE STENT OVERLAP; DEPLOYED WITHOUT DIFFICULTY. THE ISPILATERAL ILIAC LEG GRAFT WAS THEN INSERTED WITH A ONE STENT OVER LAP AND DEPLOYED WITHOUT DIFFICULTY. MOLDING BALLOON WAS USED TO MOLD THE PROXIMAL AND DISTAL SEALING ZONES ALONG WITH THE OVERLAP JUNCTION POINTS. A POST ANGIOGRAM REVEALED AN EARLY FILLING ENDOLEAK AT THE LEVEL OF THE LUMBAR ARTERIES AND AT THE JUNCTION POINT AREA OF THE STENT LEGS. MOLDING BALLOON WAS RE-INSERTED AND INFLATED IN THE IPSILATERAL LEG AT THE AREA OF THE OVERLAP BETWEEN THE ILIAC LEG EXTENSION AND THE ILIAC LEG GRAFT. ANOTHER ANGIOGRAM REVEALED THE SAME ENDOLEAK APPEARANCE AS THE FIRST. BALLOON DILATATION OF THE BIFURCATION ARE COMPLETED WITH TWO ANGIOPLASTY BALLOONS USING A "KISSING" TECHNIQUE. ANOTHER ANGIOGRAM REVEALED CONTINUED ENDOLEAK. ANOTHER MANUFACTURER'S STENT WAS DEPLOYED IN THE AREA OF THE PROXIMAL 17MM SEALING STENT OF THE MAIN BODY GRAFT. STENT WAS POST DILATED WITH A LARGE DIAMETER ANGIOPLASTY BALLOON. POST ANGIOGRAM TAKEN AND REVEALED THE CONTINUED ENDOLEAK. AN ILIAC LEG EXTENSION WAS PLACED IN THE CONTRALATERAL LEG, IN THE AREA OF THE OVERLAP OF THE ILIAC LEG GRAFT AND THE CONTRALATERAL LIMB OF THE MAIN BODY GRAFT. POST DILATATION COMPLETED AND ANOTHER ANGIOGRAM REVEALED THE CONTINUED ENDOLEAK SHOWING THE SAME ENDOLEAK DETAIL AT THE FIRST POST ANGIOGRAM. A FINAL TREATMENT WITH AN ILIAC LEG GRAFT DEPLOYED IN THE IPSILATERAL LEG, IN THE AREA OF THE OVERLAP OF THE MAIN GRAFT, THE IPSILATERAL ILIAC LEG EXTENSION, ILIAC LEG GRAFT AND THE EXPANDABLE BALLOON STENT. POST ANGIOGRAM TAKEN. REVEALING THE SAME APPEARANCE OF ENDOLEAK AS PRIOR RUNS. CSE CONCLUDED AT THAT TIME WITH THE RESULT OF A CONTINUED TYPE II ENDOLEAK. PATIENT WILL CONTINUE TO BE MONITORED. REFER TO 1820334-2003-00253 AND 1820334-2003-00254.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZENITH AAA LEG GRAFT ENDOVASCULAR GRAFT MIH COOK INC. NA 1282747

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other